Transvaginal Mesh: Complications and Safety Risks
Transvaginal mesh complications include infections, pelvic pain and painful intercourse. The FDA has issued several safety warnings over the years, and thousands of women have filed lawsuits against mesh manufacturers for injuries.
- Last update: June 30, 2025
What Is Transvaginal Mesh?
Transvaginal mesh is a synthetic, net-like surgical material that helps provide support to weakened or damaged tissue in the pelvis. It is most commonly used to treat:
- Stress urinary incontinence (SUI)
- A condition where physical movement or activity like coughing, exercising or sneezing causes involuntary urine leakage. When transvaginal mesh is used to treat stress urinary incontinence, it is sometimes referred to as a bladder sling.
- Pelvic organ prolapse (POP)
- A condition where organs like the bladder, bowel, uterus or the top of the vagina drop from their normal position and bulge into the vagina. This can be due to weakened pelvic muscles.
The mesh is implanted through the vagina during surgery, which is why it is called “transvaginal” mesh. Once in place, it acts as a sling or hammock, allowing your body’s tissues to grow into tiny holes within the mesh for added strength and stability.
When Did Surgeons Start Using Transvaginal Mesh?
Surgeons have been experimenting with mesh since the 1970s, but it wasn’t until the 1990s that doctors developed the transvaginal mesh technique. This technique shortened surgical recovery time for patients.
In 1996, the FDA approved the first pelvic mesh to treat urinary incontinence. By 2002, the FDA approved several transvaginal mesh kits for pelvic organ prolapse.
Since then, the FDA has issued several safety communications regarding complications associated with transvaginal mesh. Lawsuits against pelvic mesh manufacturers for failing to warn of the risks have led to 100,000 women receiving almost $8 billion in settlements.
Why Transvaginal Mesh Became Controversial
Transvaginal mesh became controversial due to thousands of complication reports that led to regulatory actions and concerns about patient safety.
The FDA released warnings from 2008 to 2019, which ultimately led to the agency banning transvaginal mesh for pelvic organ prolapse in 2019. However, surgeons continue to use transvaginal mesh to treat stress urinary incontinence.
Adverse physical and emotional impacts of pelvic mesh injuries led some women to file transvaginal mesh lawsuits. In 2012, Christine Scott and her husband received a jury verdict of $5.5 million after she claimed her Bard bladder sling caused her to develop complications and ruined her sex life.
So far, transvaginal mesh settlements have totaled about $8 billion, but this number is just an estimate because some settlement amounts aren’t available to the public.
Women have been filing these lawsuits for years. You can still speak to a lawyer and file a lawsuit in 2025.
Common and Serious Side Effects of Transvaginal Mesh
Transvaginal mesh complications range from less severe issues like pain to serious concerns such as mesh erosion, which causes the mesh to poke through surrounding tissues.
- Erosion or exposure of vaginal mesh
- Infection
- Mesh contraction, which is when mesh shortens and causes tightness or pain in the vagina
- Pain during sex
- Pain in the pelvis or vagina
- Vaginal bleeding or discharge
Treatments for vaginal mesh complications include pain medications, pelvic floor physical therapy and trigger point injections. More serious complications like mesh exposure typically require surgery.
In some cases, you may need more than one surgery to remove the mesh or correct complications.
FDA Warnings, Mesh Reclassification and Market Withdrawal
The FDA’s warnings for transvaginal mesh span from 2008 to 2019. They include reclassifying mesh to require more safety studies and removing certain meshes from the market.
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2008
After receiving over 1,000 reports of complications from transvaginal mesh, the FDA issued its first public health notification. The warning highlighted risks like discomfort during intercourse, erosion, infections, organ perforation, pain and vaginal scarring, but these complications were described as rare.
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2011
The FDA updated its warning, stating that complications from transvaginal mesh were not rare. Additional risks identified included bleeding, emotional distress, recurrent prolapse, urinary problems and vaginal shrinkage. The agency also considered reclassifying mesh from a low to moderate-risk Class II device to high-risk Class III device.
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2012
The FDA ordered mesh manufacturers to conduct postmarket studies to gather more safety and effectiveness data concerning mini-sling devices and surgical mesh.
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2016
The FDA reclassified transvaginal mesh for pelvic organ prolapse repair from Class II to Class III. This reclassification requires more rigorous premarket approval and is the strictest device review process.
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2019
The FDA ordered all manufacturers to stop selling and distributing transvaginal mesh for pelvic organ prolapse repair in the United States. The agency concluded that manufacturers had not demonstrated reasonable assurance of effectiveness and safety.
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2024
Based on available data for mesh slings for stress urinary incontinence, the FDA recommended that medical providers get proper training for the surgery and advise patients of the risks and benefits.
The FDA’s regulatory actions mean that women cannot receive transvaginal mesh for pelvic organ prolapse. However, transvaginal mesh slings for stress urinary incontinence are still an option.
Transvaginal Mesh Recalls and Manufacturer Withdrawals
Boston Scientific’s ProteGen Sling is the only mesh product that a manufacturer has officially recalled. Other transvaginal mesh products were either withdrawn from the market or discontinued by the manufacturers.
Companies like American Medical System, Boston Scientific, Coloplast and Johnson & Johnson’s Ethicon stopped selling some of their mesh products.
- All mesh devices by Endo International/American Medical Systems
- Boston Scientific Uphold Lite and Xenform for anterior/apical repair
- Coloplast Direct Fix A for anterior/apical repair and Direct Fix P for posterior/apical repair
- Ethicon Gynecare Prolift
- Ethicon Gynecare Prolift + M
- Ethicon Gynecare Prosima
- Ethicon Gynecare TVT Secur system
You can read more about the FDA’s actions and recalled or discontinued vaginal mesh products on our transvagnal mesh recall page.
What To Do if You’re Experiencing Mesh Complications
If you’re experiencing any transvaginal mesh complications, talk to your doctor. You may also want to see a urogynecologist, as they specialize in pelvic floor or urinary incontinence issues.
Your medical provider may recommend imaging or tests. In some cases, you may need an examination under anesthesia to see if your mesh is causing problems. Remember to keep all of your medical records, especially if you want to file a lawsuit.
You can sign up for a free case review with Drugwatch to see if you qualify for a lawsuit. We can match you with an experienced lawyer based on your unique situation, and there is never any obligation for you.
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